Quality Assurance Officer

2 days ago

Hay, United Kingdom PCI Pharma Services Full time

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

We have an exciting, permanent opportunity within our Quality Department at Hay-on-Wye for a Quality Assurance Officer to join the team on a Full Time, Permanent basis If you are able to work well as a team player and also on your own initiative and have excellent attention to detail with strong communication skills, then we would like to hear from you

Main purpose of the role:
To support the overall implementation and maintenance of the Company’s quality management systems and adherence to cGMP.

General responsibilities include but are not limited to:
- Preparation / authorisation of Master BPRs, artwork, component specifications, labels, reprocessing paperwork, pre-batch documentation, calibration records, temperature records, environmental reports, MWOs, etc.- Liaison with customers on issues relating to quality matters, presenting quality related data and attending and presenting at quality review meetings.- Assist with initiating any nonconforming events within the QMS.- Advise Senior Quality personnel of any deviation / non-conformance / abnormality observed with finished product or major non-conformance against procedure.- Complete minor complaint investigations, identify root cause and robust CAPAs to eradicate reoccurrence of issue.- Support with management of non-conformances raised within the QMS. Review and assess Events initiated, ensuring that all events are classified correctly in terms of risk and have been raised in conjunction with procedure. Determine next steps for event (ie raise to NONC or Deviation).- Review and approval of deviation reports ensuring that root cause analysis has been completed and robust actions have been identified to eradicate reoccurrence of an issue.- Communicate non-conformances with clients. Work with clients to request investigations for client non-conformances, close out when investigation complete.- Send internal Events / Deviations reports to clients in conjunction with the Quality Technical Agreement requirement. Seek approval where required.- Review of complaint investigations. Seek approval from clients on investigations as per QTA requirement.- Assisting with review of CAPA evidence and complete CAPA effectiveness reviews.- Support with change control review and approval process. Send change control notifications to clients and seek approval where required.- Assisting / Hosting / supporting client / regulatory visits / audits. Support with audit responses.- Internal auditing to confirm compliance to EU GMP and adherence to company procedure and policy.- Assist in preparation of monthly report and other reports as required e.g. client requested information.- Support NPI QA lead with Commercial and Clinical New product introduction from a quality perspective.- Design and maintenance documentation to include SOPs and Standard Documents as appropriate and as agreed with operations department.- Lead or be part of team in Continuous Improvement activities.- Record right first time issues within PCI RFT database.- Develop / maintain filing systems and the archiving of QA controlled documentation.- Assistance in other paperwork related functions within the department as required.- Take care of your own health and safety and that of people who may be affected by what you do (or do not do). Co-operate with others on health and safety, and not interfere with, or misuse, anything provided for your health, safety or welfare.

Commercial specific responsibilities include but are not limited to:
- Review of Batch Documentation prior to QP release; including completion of paperwork, resolution of deficiencies and inaccuracies, reconciliation, preparation of release documentation.- Support Compliance team with the preparation and authoring of client PQR’s.- Support with review and update of Quality Technical Agreements.- Support Quality Regulatory Affairs Manager with client regulatory requests / requirements.

Clinical Trial specific responsibilities include but are not limited to:
- Checking and / or approval of randomisation databases to include Electronic approval and locking of databases on Prisym labelling system. Electronic approval and locking of label set-up on Prisym labelling system acting as back up to project management team.- Review of Batch Documentation prior release of non-licensed products or materials; including completion of paperwork, resolution of deficiencies and inaccuracies, reconciliation, preparation of release documentation.- Approval of printing requests for clinical trials labels and additional approval of finished printed labels for print only projects where labels are despatched.- Support the QP’s with generation of QP De

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